Is this the beginning of the end of the off-label marketing ban?

If Allergan is successful in challenging this rule, then FDA approval will become meaningless. Pharmaceuticals will push drugs for any and every ailment under the sun, regardless of whether the drug has been shown to have safety or efficacy for that use. Some would say that’s the world we already live in…

Oct. 2 (Bloomberg) — Allergan Inc. is challenging a U.S. government rule that prohibits marketing its wrinkle-smoother Botox for unregulated uses, saying the policy restricts information that is needed for patients’ safety.

Doctors should get dosing guidelines and details of injection techniques to reduce risks when giving patients Botox for uses that haven’t been approved, Allergan said today. The drugmaker announced yesterday that it would file a court order enabling the distribution of such information. This is the first lawsuit challenging this aspect of the FDA’s marketing rules, according to the company.

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This blog chronicles legal and scientific news relating to personal injuries caused by defective drugs and medical devices. It is published by injury lawyer Justinian C. Lane, an attorney who takes a personal interest in each of his clients’ cases.

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Justinian Lane

Justinian C. Lane is a personal injury attorney who focuses his practice on helping individuals injured by prescription drugs and medical devices. His practice is nationwide and he welcomes e-mails at justinian@dangerousdrugs.us. His full biography is here.